Roche cobas vivoDx User guide

cobas

®

vivoDx System

User Guide

Publication version 1.2

Software version 1.0

2

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Publication information

Publication version Software version Revision date Change description

1.0 1.0 November 2018 First version

1.1 1.0 February 2019 Procedures to clean and to decontaminate the system updated,

list of maintenance intervals updated, and minor updates.

u What is new in publication version 1.1 (12)

1.2 1.0 October 2019 New procedure to recover the instrument after a power surge

or electrical burst.

u What is new in publication version 1.2 (12)

y Revision history

Edition notice

This publication is intended for users of the cobas

®

vivoDx System.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before

you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

r Store all publications in a safe and easily accessible

place.

Training

Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Images

The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.

Configurable and variable data in screenshots, such as

tests, results, or path names visible therein must not be

used for laboratory purposes.

3

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Warranty

Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative, or perform such updates with their

assistance.

Copyright

reserved.

License information

The cobas

®

vivoDx Software is protected by contract

law, copyright law, and international treaties. The

cobas

®

vivoDx Software contains a user license between

F. Hoffmann-La Roche Ltd. and a license holder, and

only authorized users may access the software and use

it. Unauthorized use and distribution may result in civil

and criminal penalties.

Open-source and commercial software

cobas

®

vivoDx System may include components or

modules of commercial or open-source software. For

further information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in the cobas

®

vivoDx System, refer to

the electronic distribution included with this product.

This open-source and commercial software and the

cobas

®

vivoDx System as a whole can constitute a

device regulated in accordance with applicable law. For

more detailed information, refer to the corresponding

user documentation and labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to the cobas

®

vivoDx

System.

Trademarks

The following trademarks are acknowledged:

COBAS and LIFE NEEDS ANSWERS are trademarks of

Roche.

All other trademarks are the property of their respective

owners.

4

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Feedback

Every effort has been made to ensure that this

publication fulfills the intended use. All feedback on any

aspect of this publication is welcome and is considered

during updates. Contact your Roche representative,

should you have any such feedback.

Approvals

The cobas

®

vivoDx System meets the requirements laid

down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use

of certain hazardous substances in electrical and

electronic equipment.

Complies with 21 CFR 1040.10 and 1040.11 except for

deviations pursuant to Laser Notice No. 50, dated June

24, 2007.

Compliance with the applicable directives is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

'Laboratory Equipment' is the product identifier as

shown on the name plate.

5

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Contact addresses

Distributed in the United States by:

Roche Diagnostics

9115 Hague Road

Indianapolis, IN 46256

USA

Roche Molecular Systems, Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Made in USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

6

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

7Table of contents

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Table of contents

Publication information 2

Contact addresses 5

Intended use 9

Symbols and abbreviations 9

What is new in publication version 1.2 12

What is new in publication version 1.1 12

Safety

1 Safety information

Safety classifications 19

Safety precautions 20

Safety labels on the system 22

Safety information for lasers 25

Safety information for disposal 26

System description

2 Overview of the system

About the cobas

®

vivoDx System

31

Overview of the instrument 32

Overview of the user interface 36

Reagents and consumables 37

List of system specifications 40

3 User Assistance

Overview of the User Assistance 45

Accessing the User Assistance from the

instrument software 46

Operation

4 Routine operation

Overview of routine tasks 53

Frequently performed tasks 59

Before routine operation 63

During routine operation 67

After routine operation 82

Non-routine operation 87

5 Maintenance

List of maintenance intervals 97

Cleaning the system 98

Decontaminating the system 99

Label printer maintenance 101

6 Configuration

User management 105

Selecting default printers 110

Editing the lab name and address 112

Configuring test result options 113

7 Troubleshooting

Viewing test cartridge errors in racks 117

Exporting support data 118

Taking a screenshot 120

No communication between instrument and

tablet 121

Issues scanning barcode on reagent cap 125

Barcode reader not responding 126

Test cartridge not processed 127

Keyboard not responding 128

Printer not responding 129

Removing a test cartridge from inside the

instrument 130

Instrument not responding after a power

surge or electrical burst 131

Glossary

Index

8

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

9

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Intended use

The cobas

®

vivoDx System supports an automated

workflow incorporating Smarticles technology for the

rapid detection, identification, and/or determination of

antimicrobial susceptibility of viable (live) bacteria,

directly for clinical specimens, positive cultures, or

clinical isolates, as applied in laboratories and other

healthcare settings. The cobas

®

vivoDx System

combines the functionalities of instrumentation,

consumables, reagents, and data management to provide

an efficient workflow from sample processing to result

interpretation. The system adds assay-specific Smarticles

bioparticles to human specimens, or samples prepared

from positive cultures or clinical isolates, and then

detects the presence or absence of specific organisms

and, if antibiotics are added to the assay, can determine

the antimicrobial susceptibility phenotype of the target

organism(s) in the sample.

Intended use statements for tests on the cobas

®

vivoDx

System are located within the Instructions for Use for

respective tests run on the system.

Symbols and abbreviations

Product names

Except where the context clearly indicates otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobas

®

vivoDx System

system

cobas

®

vivoDx Instrument

instrument

cobas

®

vivoDx Software

software

y Product names

Symbols used in the publication

Symbol Explanation

o

List item.

u

Related topics containing further information.

r

Start of a task.

q

Tip. Extra information on correct use or useful

hints.

I

Extra information within a task.

y Symbols used in the publication

10

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Symbol Explanation

f

Result of an action within a task.

c

Frequency of a task.

n

Duration of a task.

d

Materials that are required for a task.

j

Prerequisites of a task.

u

Topic. Used in cross-references to topics.

p

Task. Used in cross-references to tasks.

w

Figure. Used in figure titles and cross-

references to figures.

y

Table. Used in table titles and cross-references

to tables.

Home tab in the User Assistance.

Search tab in the User Assistance.

Table of contents tab in the User Assistance.

History tab in the User Assistance to show

previously viewed topics.

Favorites. Used in the User Assistance on the

favorites tab and on the content panel.

Enlarge. Button used on images.

y Symbols used in the publication

Symbols used on product

Symbol Explanation

Global Trade Item Number

Catalog number

Serial number

Indicates that the equipment is suitable for

alternating current only; to identify relevant

terminals.

Manufacturer

y Symbols used on product

11

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Symbol Explanation

Authorized representative in the EC

Date of manufacture

Caution

Quantity contained in the package

Product order

Complies with the directive 2011/65/EU on

RoHS

y Symbols used on product

Abbreviations

The following abbreviations are used:

Abbreviation Definition

ANSI American National Standards Institute

EC European Community

EMC Electromagnetic compatibility

EN European standard

IEC International Electrotechnical Commission

ISO International Organization for

Standardization

IVD In vitro diagnostic

LAN Local Area Network

LIS Laboratory information system

p.a. pro analysi, analytically pure

RF Radio frequency

UL Underwriters Laboratories Inc.

USB Universal Serial Bus

WEEE Waste Electrical and Electronic Equipment

y Abbreviations

12

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

What is new in publication version 1.2

Safety information about data security

Updated information regarding data security in case of

power interruption.

u Data security (20)

Electromagnetic compatibility

Updated safety information about electromagnetic

compatibility. New information about environmental

conditions related to electromagnetic compatibility.

u Electromagnetic compatibility (EMC) (21)

u Environmental conditions (40)

Troubleshooting information for the

instrument after a power surge or electrical

burst

New troubleshooting information to recover the

instrument after a power surge or electrical burst.

u Instrument not responding after a power surge or

electrical burst (131)

What is new in publication version 1.1

Maintenance intervals

The following maintenance intervals have been updated:

• Mention to preventive maintenance added.

• Daily maintenance removed.

• Interval of decontamination procedure changed from

every 6 months to as required.

u List of maintenance intervals (97)

Cleaning the system

Removed steps to clean racks.

u Cleaning the system (98)

Decontaminating the system

The requirement to decontaminate the system every 6

months has been removed.

It is not required to use a new swab for each rack

position.

After cleaning the interior of rack positions, it is not

needed to wipe them.

13

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

u Decontaminating the system (99)

14

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Safety

1 Safety information.........................................................................................17

17

Table of contents

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Safety information

In this chapter

1

Safety classifications............................................................. 19

Safety precautions................................................................. 20

Safety labels on the system................................................ 22

List of safety labels on the system ....................... 22

Location of safety labels on the system ............. 23

Safety information for lasers.............................................. 25

Safety information for disposal......................................... 26

1 Safety information

18

Table of contents

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

1 Safety information

19Safety information

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Safety classifications

The safety precautions and important user notes are

classified according to the ANSIZ535.6-2011 standard.

Familiarize yourself with the following meanings and

icons:

Safety alert

r The safety alert symbol is used to alert you to

potential physical injury hazards. Obey all safety

messages that follow this symbol to avoid possible

damage to the system, injury, or death.

These symbols and signal words are used for specific

hazards:

WARNING!

Warning...

r ...indicates a hazardous situation which, if not

avoided, could result in death or serious injury.

CAUTION!

Caution...

r ...indicates a hazardous situation which, if not

avoided, could result in minor or moderate injury.

NOTICE!

Notice...

r ...indicates a hazardous situation that, if not avoided,

may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

i

Tip...

...indicates additional information on correct use

or useful tips.

1 Safety information

20 Safety precautions

Roche Diagnostics

cobas

®

vivoDx System · Software version 1.0 · User Guide · Publication version 1.2

Safety precautions

Data security

CAUTION!

Power interruption

To avoid data loss or system damage due to a power

surge or a power interruption or voltage drop:

r It is recommended to use an uninterruptible power

supply (UPS) for power conditioning.

r Ensure regular maintenance of the UPS.

CAUTION!

Data loss or unavailability of the system due to

malicious software or unauthorized system access

Malicious software or unauthorized system access can

result in data loss or system unavailability.

To avoid infection by malicious software or the

unauthorized access and misuse of the system, the

following recommendations are essential:

r Make sure other computers and services on the

network (for example, the LIS, archiving share,

backup share, or service) are properly secured and

protected against malicious software and

unauthorized access.

r The Roche-provided firewall is mandatory if the

system is connected to the network.

r Restrict physical access to the system and all

attached IT infrastructure (computer, cables, network

equipment, and so on).

r Check all external storage devices, like USB flash

drives, with an antivirus scanner (on another

computer) to ensure that they are free of malicious

software, before using them on the system.

r Allow only internet access to trusted web sites and

web services.

1 Safety information

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Roche cobas vivoDx User guide

Roche cobas vivoDx User guide

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